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Trial record 13 of 730 for:    Area Under Curve AND Bioavailability

Relative Bioavailability of Iron and Folic Acid in New Test Supplement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00789490
Recruitment Status : Completed
First Posted : November 13, 2008
Last Update Posted : November 13, 2008
The Hospital for Sick Children
Heinz Endowments
Information provided by:
University of Toronto

Brief Summary:
Deficiencies of iron and folic acid during pregnancy can lead to adverse outcomes for the fetus, thus supplements are recommended. Adherence to current tablet-based supplements is documented to be poor. Recently a powdered form of micronutrients has been developed which may decrease side-effects and thus improve adherence. However, before testing the efficacy of the supplement as an alternate choice for supplementation during pregnancy, the bioavailability of the iron needs to be determined. The objective of this study is to measure the relative bioavailability of iron and folic acid from a powdered supplement that can be sprinkled on semi-solid foods or beverages versus a traditional tablet supplement in pregnant women.

Condition or disease Intervention/treatment Phase
Iron Deficiency Folic Acid Deficiency Dietary Supplement: Daminaide 995 - SuppleFem Sprinkles Dietary Supplement: Materna Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Relative Bioavailability of Iron and Folic Acid From a New Powdered Supplement Compared to a Traditional Tablet in Pregnant Women
Study Start Date : October 2005
Actual Primary Completion Date : July 2006
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

Intervention Details:
  • Dietary Supplement: Daminaide 995 - SuppleFem Sprinkles
    The study agent SuppleFem will be a preblend manufactured by Acatris in Oakville Ontario and will be repackaged into 1 gram aliquots in white plastic Tamper Seal Vials.1 ram to be taken with test meal
  • Dietary Supplement: Materna
    Materna is a pregnancy supplement available on the Canadian market and is manufactured by Wyeth. Dose is 1 tablet per day

Primary Outcome Measures :
  1. The primary outcome is a comparison of area under the curve (AUC) for change in serum iron for each intervention adjusted for diurnal variation. The use of AUC will provide a single outcome for each participant. [ Time Frame: 3 weeks ]

Secondary Outcome Measures :
  1. The secondary outcome is a comparison of area under the curve (AUC) for change in serum folate for each intervention [ Time Frame: 2 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy pregnant women between 18 and 45 years of age in the second or third trimester of pregnancy (24-32 weeks of gestational age).
  • Normal Hb (Hb≥110g/L and Hb≤144g/L)

Exclusion Criteria:

Chronic illness (clinically significant neurological, endocrine, cardiovascular, pulmonary, hematologic, immunologic, psychiatric or metabolic diseases)

  • A history or presence of hemosiderosis, hemochromatosis, peptic ulcer, regional enteritis, ulcerative colitis
  • A history of or current use of IV iron therapy or erythropoietin therapy
  • A history or presence of any clinically significant gastrointestinal pathology (eg. chronic diarrhea, inflammatory bowel disease, partial gastrectomy), unresolved gastrointestinal symptoms (eg. diarrhea or vomiting), steatorrhea, or other conditions known to interfere with the absorption, distribution, metabolism or excretion of iron or folic acid
  • Abnormal hemoglobin electrophoresis ie. sickle cell anemia, thalassemia, etc.
  • Current acute illness and/or taking antibiotics
  • Known or suspected allergies to Materna®, or any ingredient present in Materna or SuppleFem Sprinkles or any of the foods to be consumed during the trial.
  • Mildly to severely anemic women (Hb<110 g/L) or elevated hemoglobin (above 144g/L)
  • Complications in pregnancy (including pregnancy induced hypertension, preeclampsia, a history of severe antepartum hemorrhage)
  • Blood transfusion within last 3 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00789490

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Canada, Ontario
The Hospital For Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
University of Toronto
The Hospital for Sick Children
Heinz Endowments

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dr Stanley Zlotkin M.D, PhD, FRCP (C), The Hospital For Sick Children Identifier: NCT00789490     History of Changes
Other Study ID Numbers: Sickkids REB 1000007811
First Posted: November 13, 2008    Key Record Dates
Last Update Posted: November 13, 2008
Last Verified: November 2008
Keywords provided by University of Toronto:
relative bioavailability
folic acid
ferric pyrophosphate
Study focus is to compare the relative bioavailability of SuppleFem Sprinkles to the current tradtional tablet Materna in pregnant women
Additional relevant MeSH terms:
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Folic Acid Deficiency
Vitamin B Deficiency
Deficiency Diseases
Nutrition Disorders
Folic Acid
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs